510(k) Report

Devices descending from K081666

337 later devices reach Atlantis, Atlantis Gemini, Atlantis Gemini+ Abutments for Astra Osseospeed 3.0… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+3K191382IPS e.max CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20193—
+3K182091Osstem Abutment SystemOsstem Implant Co., Ltd.201930—
+3K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+3K182246Mist ICImagine Milling Technologies, LLC20194—
+3K181932DTX Studio designNobel Biocare AB20190—
+3K180564Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBasesMedentika GmbH20192—
+3K181850Inversa ImplantsSouthern Implants (Pty), Ltd.20180—
+3K173945Straumann SC Variobase AbutmentsInstitut Straumann AG20180—
+3K180465Provata Implant SystemSouthern Implants (Pty), Ltd.20182—
+3K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+3K173706Piccolo Implants and AccessoriesSouthern Implants (Pty), Ltd.20180—
+3K180609Rodo SmilekeyRodo Medical, Inc.20180—
+3K171773Straumann n!ce Glass Ceramic A14 BlocksInstitut Straumann AG20170—
+3K170394Kisses MiniAchimhai Medical Corporation20170—
+3K160626ATLANTIS Abutment for HIOSSEN ET implantDentsply Sirona20169—
+3K151789LOCATOR F-Tx Attachment SystemZest Anchors, LLC20168—
+3K151039ATLANTIS Abutment for NobelActive 3.0Dentsply International, Inc.20161—
+3K150203Medentika CAD/CAM AbutmentsMedentika GmbH2015129—
+3K151599iSy Implant SystemAltatec GmbH20150—
+3K151564Telio CAD Abutment SolutionsIvoclar Vivadent, AG20151—
+3K142557Anker Dental Implant System - SB-III, ST and AT seriesAlliance Global Technology Co., Ltd.20150—
+3K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S201589—
+3K142890Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase…Straumann USA, LLC201530—
+3K132219Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase (TM) Abutment RN…Straumann USA, LLC201435—
+3K132125A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd.201425—
+3K122295Core 3D Abutment System for Digital Prosthetic SolutionsCore 3D Protech, S.L.201329—
+3K112440AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd.201236—
+4K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+4K253774Elos Accurate® Denture Fixation SystemElos Medtech Pinol A/S20260—
+4K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG20260—
+4K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+4K251427EK Multi Angled 30 AbutmentHiossen, Inc.20260—
+4K253341Custom Abutments ASMedentika GmbH20250—
+4K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+4K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+4K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+4K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+4K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+4K243824Preat AbutmentsPreat Corporation20250—
+4K250295Dentsply Sirona Titanium Bases systemDentsply Sirona20250—
+4K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+4K232383iPhysio® SystemEuroteknika20250—
+4K241972Bluediamond ImplantMegagen Implant Co., Ltd.20240—
+4K233252Straumann CARES Visual and Nova Dental CADInstitut Straumann AG20240—
+4K241616ALLONUS Tech ProstheticsAllonus Tech Co., Ltd.20240—
+4K231566ICX-Implant SystemMedentis Medical GmbH20240—
+4K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+4K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+4K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc.20242—
+4K233285KATANA Zirconia ONE For IMPLANTKuraray Noritake Dental, Inc.20240—
+4K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+4K231529CloudPoint FastDesign ChairsidePrismatik Dentalcraft, Inc.20240—
+4K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+4K233194TS Abutment SystemOsstem Implant Co., Ltd.20242—
+4K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+4K231072Anthogyr FlexiBase® titanium bases for Axiom® BLAnthogyr20240—
+4K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+4K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+4K232560Angled AbutmentArum Dentistry Co., Ltd.20231—
+4K231429S-Plant Dental Implant SystemIdis Co., Ltd.20230—
+4K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+4K231127S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20232—
+4K231559Multi-Unit DAS SystemTalladium España, SL20231—
+4K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+4K232151Dynamic TiBaseTalladium España, SL20232—
+4K221107TRUSTRgorithm Korea20230—
+4K222636ET Abutment SystemHiossen, Inc.20230—
+4K221402CEREC Tessera Abutment Block, CEREC Tessera Abutment SystemDentsply Sirona, Inc.20232—
+4K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+4K191111DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH20231—
+4K222368Mist ICImagine Milling Technologies, LLC20222—
+4K220562TiGEN Abutment, ZrGEN Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20225—
+4K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+4K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20223—
+4K221684Osstem Abutment SystemOsstem Implant Co., Ltd.20220—
+4K211090ZENEX Implant SystemIzenimplant Co., Ltd.20228—
+4K213391High Retention Attachment SystemZest Anchors, LLC20227—
+4K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+4K212664SherlockOpen Implants, LLC20212—
+4K211225MIS Ti-base abutmentDentsply Sirona20210—
+4K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+4K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+4K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+4K202269PRE-MILLED AbutmentMit Global Co., Ltd.20200—
+4K193193Telio CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20200—
+4K200355Duranext AbutmentsElegant Dental Corp.20200—
+4K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd.20200—
+4K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+4K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+4K182455A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20190—
+4K180968AlphaDent Implants Dental Implants SystemAlphadent Implants, Ltd.20190—
+4K181037DIO CAD/CAM AbutmentDio Corporation20187—
+4K173379Straumann Variobase for Crown ASInstitut Straumann AG20180—
+4K171799Elos Accurate Customized Abutment, Elos Prosthetic ScrewElos Medtech Pinol A/S201815—
+4K171622Dentium Ti-BaseDentium Co., Ltd.20180—
+4K172225Atlantis Abutment for MIS ImplantDentsply Sirona20178—
+4K162482A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20174—
+4K170838Medentika CAD/CAM TiBasesMedentika GmbH20174—
+4K170354Straumann Variobase AbutmentsInstitut Straumann AG20170—